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A pilot trial of adding maraviroc to suppressive antiretroviral therapy for suboptimal CD4⁺ T-cell recovery despite sustained virologic suppression: ACTG A5256.
- Source :
-
The Journal of infectious diseases [J Infect Dis] 2012 Aug 15; Vol. 206 (4), pp. 534-42. Date of Electronic Publication: 2012 Jun 27. - Publication Year :
- 2012
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Abstract
- Background: Despite viral suppression, antiretroviral therapy (ART) does not restore CD4(+) T-cell counts in many patients infected with human immunodeficiency virus type 1 (HIV-1).<br />Methods: In a single-arm pilot trial involving ART recipients with suppressed plasma levels of HIV-1 RNA for at least 48 weeks and stable suboptimal CD4(+) T-cell recovery, subjects added maraviroc, a CCR5 antagonist, to their existing ART for 24 weeks. After stopping maraviroc, they were followed for an additional 24 weeks. A Wilcoxon signed-rank test was used to evaluate whether maraviroc was associated with an increase of at least 20 cells/µL in the CD4(+) T-cell count.<br />Results: A total of 34 subjects were enrolled. The median age was 50 years, and the median baseline CD4(+) T-cell count was 153 cells/µL. The median increase in CD4(+) T-cell count from baseline to week 22/24 was 12 cells/µL (90% confidence interval, 1-22). A CD4(+) T-cell count increase of at least 20 cells/µL was not detected (P = .97). Markers of immune activation and apoptosis decreased during maraviroc intensification; this decline partially reversed after discontinuing maraviroc.<br />Conclusions: Adding maraviroc to suppressive ART for 24 weeks was not associated with an increase in CD4(+) T-cell counts of at least 20 cells/µL. Further studies of CCR5 antagonists in the dampening of immune activation associated with HIV infection are warranted. Clinical Trials Registration. NCT 00709111.
- Subjects :
- Adolescent
Adult
Aged
Aged, 80 and over
CD4 Lymphocyte Count
Female
HIV Infections virology
HIV-1 isolation & purification
Humans
Male
Maraviroc
Middle Aged
Viral Load
Young Adult
Anti-HIV Agents administration & dosage
Antiretroviral Therapy, Highly Active methods
Cyclohexanes therapeutic use
HIV Infections drug therapy
HIV Infections immunology
Triazoles therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1537-6613
- Volume :
- 206
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- The Journal of infectious diseases
- Publication Type :
- Academic Journal
- Accession number :
- 22740718
- Full Text :
- https://doi.org/10.1093/infdis/jis376